(87 days)
The M1730B TraceMaster ECG System is a computer system which allows viewing, manual editing, printing, and archiving of digitized electrocardiograph records from Hewlett-Packard company electrocardiograph machines.
The HP M1730B TraceMaster is an advanced data management system that automates the processing and storage of ECGs from HP PageWriter cardiographs. Its high-performance Pentium™ computer stores up to 750,000 ECGs on high-speed, online disks and produces clean, permanent traces on a HP LaserJet printer. The multitasking operating system smoothly handles the rigorous demands of simultaneous editing, printing, reception, and storage of ECGs. A powerful client/server network can spread the workload of editing, transmitting, and printing to M1776B Local Edit Stations, LAN-connected HP LaserJet printers, and M1798B Remote Edit Stations. Electrocardiograms can be transferred from HP electrocardiographs to the TraceMaster via the Local Area Network or floppy diskettes. On the Edit Stations users can then view the ECG and the interpretation performed by the electrocardiograph, compare to previous waveforms and interpretations, and overread and edit the interpretation. Remote Edit Stations can be connected via the Local Area Network or modem.
The acceptance criteria for the M1730B TraceMaster ECG System are primarily based on non-clinical performance aspects related to data management, storage, and electromagnetic compatibility. The study described in the provided text focuses on demonstrating these non-clinical aspects and comparing the device's capabilities to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Throughput Capacity | |
| Handle a specific number of ECGs per year | Up to 56,000 ECGs per year |
| Storage Capacity | |
| Store a specific number of ECGs online | 750,000 ECGs online |
| Essential Functions Compliance | |
| Meet all requirements specifications for essential functions | Tested and found to meet all requirements specifications. |
| Electromagnetic Compatibility (EMC) | |
| IEC 801-2 Compliance | Tested (included in IEC 801-2 test) |
| IEC 801-3 Compliance | Tested (included in IEC 801-3 test) |
| IEC 801-4 Compliance | Tested (included in IEC 801-4 test) |
| CISPR22:1993, class A (Emissions) Compliance | Tested for emissions of radio-frequency and mains current in accordance with CISPR22:1993, class A. |
| Equivalence to Predicate Device (functional subset) | |
| Performance is a subset of the features in the predicate device | Demonstrated that performance is a subset of the predicate device's features. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not specify a "test set" in the context of clinical data or patient ECGs. The testing described is primarily focused on the system's technical performance, not its diagnostic accuracy or clinical utility with a specific set of patient data. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature for such a test set are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the study did not involve establishing ground truth for a clinical test set from human experts. The device's function is ECG management (viewing, editing, printing, archiving), not automated interpretation.
4. Adjudication Method for the Test Set
This information is not applicable as there was no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The device's primary function is a management system, not an AI-powered diagnostic tool that directly aids human readers in interpretation. The text explicitly states, "TraceMaster does not perform any computerized interpretation of the ECG waveform."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The testing described is inherently "standalone" in the sense that it evaluates the system's technical capabilities (throughput, storage, EMC) as an algorithm/system, without reference to human interaction for diagnostic interpretation. However, it's important to clarify that this "standalone" refers to the system's technical functionality, not its diagnostic performance as an AI algorithm would typically be evaluated. The device's intended use specifies "manual editing" by users, indicating a human-in-the-loop for interpretations, though the system itself does not perform automated interpretation.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, expert consensus) is not applicable here. The "ground truth" for the non-clinical tests would be the established engineering and performance specifications for throughput, storage, and electromagnetic compliance. For example, for throughput, the ground truth is simply whether the system processes 56,000 ECGs per year.
8. The Sample Size for the Training Set
There is no mention of a training set in the context of machine learning or AI. The M1730B TraceMaster ECG System does not perform computerized interpretation, meaning it does not have an AI algorithm that would require a training set to learn from data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there was no training set for an AI algorithm.
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510(k) Summary for M1730B TraceMaster ECG System
FEB 1 9 1998
- Date this summary was prepared: November 20, 1997 1.
- Submitter's Name and Address
Hewlett-Packard Company 3000 Minuteman Road Andover, MA 01810-1099
- Contact Person 3.
Mr. George Diller
| Telephone | (978)659-4971 |
|---|---|
| Telefax | (978)659-3168 |
-
- Device Name
M1730B TraceMaster ECG System Proprietary Name: M1766B Local Edit Station M1798B Remote Edit Station
- Device Name
ECG Management System Common Name:
Classification Name: unknown
-
- Predicate Devices
The legally marketed device to which equivalence is being claimed is the Muse 5000 System manufactured by Marquette Electronics, Inc. (K840932). The design of TraceMaster is substantially equivalent in safety and performance to a subset of the Muse 5000 features, with the important exception that TraceMaster does not perform any computerized interpretation of the ECG waveform.
- Predicate Devices
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-
- Device Description
The HP M1730B TraceMaster is an advanced data management system that automates the processing and storage of ECGs from HP PageWriter cardiographs. Its high-performance Pentium™ computer stores up to 750,000 ECGs on high-speed, online disks and produces clean, permanent traces on a HP LaserJet printer. The multitasking operating system smoothly handles the rigorous demands of simultaneous editing, printing, reception, and storage of ECGs. A powerful client/server network can spread the workload of editing, transmitting, and printing to M1776B Local Edit Stations, LAN-connected HP LaserJet printers, and M1798B Remote Edit Stations.
- Device Description
Electrocardiograms can be transferred from HP electrocardiographs to the TraceMaster via the Local Area Network or floppy diskettes. On the Edit Stations users can then view the ECG and the interpretation performed by the electrocardiograph, compare to previous waveforms and interpretations, and overread and edit the interpretation. Remote Edit Stations can be connected via the Local Area Network or modem.
-
- Intended Use
The M1730B TraceMaster ECG System is a computer system which allows viewing, manual editing, printing and archiving of digitized electrocardiograph records from from Hewlett-Packard Company electrocardiograph machines.
- Intended Use
Comparison of Technological Characteristics 8.
The M1730B TraceMaster ECG System and the Muse 5000 both are PC bases systems utilizing commercial operating systems and networking software. They have similar geometry and construction.
The TraceMaster can handle a throughput of up to 56,000 ECGs per year, while the Muse 5000 can handle at least 30,000. The TraceMaster can store 750,000 ECGs on-line, while the Muse 5000 can store up to 1.1 million. Both offer viewing and editing on a video screen, hard copy printouts, and connection to the electrocardiograph via direct connect, removable diskette, or modem. Both systems feature a serial comparison function which shows waveform differences between successive ECGs.
An important difference is that TraceMaster does not perform any computerized interpretation of the ECG waveform.
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- Nonclinical Tests Used in Determination of Substantial Equivalence 9.
The M1730B TraceMaster ECG System was tested for Electromagnetic Immunity tests included IEC 801-2, IEC 801-3, and Compatibility. IEC801-4.
Emissions were tested to measure the emission of radio-frequency Eimssions were "tested" to "meaber" and the mains in accordance with CISPR22:1993, class A.
The essential functions of the M1730B TraceMaster ECG System have been I he essential functions of the M17562 Fraces and was found to meet all requirements specifications.
- Conclusions From Nonclinical Testing 10.
The testing of the M1730B TraceMaster ECG System demonstrates that the The testing of the NFT 50D Tracemance is a subset of the features in the predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
FEB 1 9 1998
Mr. Steven A. Clarke Staff Consultant Medical Device Consultants, Inc. 49 Plain Street 02760 North Attleboro, MA
K974420 Re: M1730 TraceMaster ECG System Trade Name: Regulatory Class: II (two) Product Code: 74 DSH Dated: November 20, 1997 November 24, 1997 Received:
Dear Mr. Clarke:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through-periodic GMP ------inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements requlatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Steven A. Clarke
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callaha Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1 __
510(k) Number:__K974420
Device Name: Mi730 TraceMaster ECG Systeml
Indications For Use:
The M1730B TraceMaster ECG System is a computer system which allows viewing, manual editing, printing, and archiving of digitized electrocardiograph records from Hewlett-Packard company electrocardiograph machines.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
for PBT
(Divjsion Sign-Off) / Division of Cardiovascular, Respiratory, and Neurological Devices K974420 510(k) Number.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).